Zydus and ICMR Launch Clinical Trials for Sickle Cell Treatment
Monday, 14 October 2024, 18:13 IST
ICMR Partners with Zydus to Conduct the Clinical Trial of the Drug That Can Potentially Cure Diseases Caused by Sickle Cell.The Indian Council of Medical Research signed a Memorandum of Agreement with Zydus Lifesciences to initiate the Phase 2 clinical trial of the drug, Desidustat, for the treatment of patients affected with sickle cell diseases. The two parties agreed to conduct a double-blind, randomized and placebo-controlled Phase IIa study relative to the assessment of the safety and efficacy of the drug.
The sanction comes when the DCGI has allowed the conducting of Phase IIa trial meant to see how well Desidustat would perform in combating a genetic disorder of abnormal hemoglobin, sickle cell disease.
Desidustat is an inhibitor of the HIF-prolyl hydroxylases-it directly acts by blocking the degradation of HIF. That causes a high level of erythropoietin-a hormone that triggers the production of red blood cells when its concentration in the blood becomes low.
Developed in India, Desidustat has opened vistas of hope for such a patient who needs yet another therapy beyond the standard available today: hydroxyurea," secretary of the Department of Health Research and director general of ICMR, Dr Rajiv Bahl said. Cooperation is important by the company to advance clinical research in India through public-private partnerships, he added.
The primary endpoint will be that the patients at week 4 and week 8, post-infusion, with an increase of more than 1 g/dL in Hb levels from baseline. Other secondary endpoints will include average changes in Hb levels, patients requiring blood transfusions, cases of vaso-occlusive crises, and percentage changes in HbSS, which is severely deficient in 65% of cases.
Public-private partnerships will be significant for new drug developments; more so in the case of the National Sickle Cell Anaemia Elimination Mission. As Pankaj Patel, Chairman of Zydus, has articulated, "This research initiative brings renewed hope to the approximate 20 million people in India suffering from sickle cell disease, offering a promising novel treatment.".
Zydus has developed the compound at their research and development facilities. The innovative molecule recently earned approval in the US to treat anemia associated with chronic kidney diseases.
Among the major public health issues that India still suffers from is sickle cell disease, particularly in certain tribal societies. The National Health Mission estimates believe that almost 20 million people are suffering from this condition across the country, while 50,000 children are born in India every year suffering with sickle cell anemia.
The sanction comes when the DCGI has allowed the conducting of Phase IIa trial meant to see how well Desidustat would perform in combating a genetic disorder of abnormal hemoglobin, sickle cell disease.
Desidustat is an inhibitor of the HIF-prolyl hydroxylases-it directly acts by blocking the degradation of HIF. That causes a high level of erythropoietin-a hormone that triggers the production of red blood cells when its concentration in the blood becomes low.
Developed in India, Desidustat has opened vistas of hope for such a patient who needs yet another therapy beyond the standard available today: hydroxyurea," secretary of the Department of Health Research and director general of ICMR, Dr Rajiv Bahl said. Cooperation is important by the company to advance clinical research in India through public-private partnerships, he added.
The primary endpoint will be that the patients at week 4 and week 8, post-infusion, with an increase of more than 1 g/dL in Hb levels from baseline. Other secondary endpoints will include average changes in Hb levels, patients requiring blood transfusions, cases of vaso-occlusive crises, and percentage changes in HbSS, which is severely deficient in 65% of cases.
Public-private partnerships will be significant for new drug developments; more so in the case of the National Sickle Cell Anaemia Elimination Mission. As Pankaj Patel, Chairman of Zydus, has articulated, "This research initiative brings renewed hope to the approximate 20 million people in India suffering from sickle cell disease, offering a promising novel treatment.".
Zydus has developed the compound at their research and development facilities. The innovative molecule recently earned approval in the US to treat anemia associated with chronic kidney diseases.
Among the major public health issues that India still suffers from is sickle cell disease, particularly in certain tribal societies. The National Health Mission estimates believe that almost 20 million people are suffering from this condition across the country, while 50,000 children are born in India every year suffering with sickle cell anemia.
